NCT07456462 · NOT YET RECRUITING
Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance
This study is testing whether advanced MRI scans and blood tests can predict how well lecanemab or donanemab are working in people with early Alzheimer's disease or MCI — without relying on repeated PET scans. It is not a drug trial; the antibody treatments are given as standard care. Researchers will build personalized computer models to track amyloid clearance over 18 months. This is a Phase NA observational study at one site in Milan, Italy, enrolling 50 participants.
Eligibility criteria
Inclusion Criteria:
1Participant is willing and able to give informed consent for participation in the study.
2. Participant is eligible for anti-amyloid therapy (AAT), i.e.:
* Participants aged 30-90.
* Diagnosis of early symptomatic AD, including MCI or mild dementia [2].
* Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0
* Confirmed amyloid pathology through CSF or PET imaging. 3. Participant is willing to start Anti-amyloid therapy as part of his/her clinical-practice- therapeutic plan.
4. For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional four weeks after the end of study.
5. For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
Exclusion Criteria:
* 1. Contraindications to AAT, including:
* Significant neurological diseases other than AD that could affect cognition or study participation (e.g., other dementias, serious brain infections, Parkinson's disease, multiple concussions, epilepsy with recurrent seizures).
* Homozygous ApoE4 genotype.
* Current use of anticoagulant therapy.
* Vascular abnormalities: Presence of more than 4 microhemorrhages (defined as ≤10 mm in greatest diameter), a single macrohemorrhage >10 mm, superficial siderosis, evidence of vasogenic edema, multiple lacunar infarcts, or stroke involving a major vascular territory.
* Amyloid-Related Imaging Abnormalities (ARIA): Evidence of ARIA, including cerebral amyloid angiopathy-related inflammation (CAA-ri) or amyloid beta-related angiitis (ABRA).
* Bleeding disorders: History of bleeding disorders not under adequate control, including a platelet count \<50,000 or international normalized ratio (INR) >1.5 for participants not on anticoagulant therapy.
* Being currently under treatment with another AAT other than lecanemab/donanemab (e.g. as part of a Clinical Trial).
2. Current serious or unstable illnesses, including:
* Cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic diseases.
* Conditions that, in the clinician's opinion, could interfere with study analyses or with a life expectancy of less than 24 months.
* History of cancer within the last 5 years, except for non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer, or other cancers with low risk of recurrence.
3. Inability to undergo MRI or PET imaging procedures (e.g. non-MRI safe pacemaker or devices, claustrophobia etc).
4. Women of childbearing potential who are not using adequate contraception, as well as pregnant or breastfeeding women.The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-03-06